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Evaluation of a Gel Sunscreen in Controlled Use Conditions (208/2016)

Evaluation of a Gel Sunscreen in Controlled Use Conditions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03012347
Enrollment
72
Registered
2017-01-06
Start date
2017-01-05
Completion date
2017-01-19
Last updated
2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sunscreening Agents

Brief summary

To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use testing, in a controlled indoor environment

Interventions

DRUGBAY987517

Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity. (Formulation: RB# Y73-161)

DRUGBullFrog Gel Sunscreen Land Sport SPF-50

Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity.

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Subjects may be male or female. * Subjects must be adults between 18 and 45 years of age. * Subjects must have and have had a consistently active lifestyle for at least the previous few years (exercise * outdoors and in direct sun exposure at least 2 times per week for at least 30 minutes-acceptable activities include tennis, running, jogging, walking, golf, etc.), i.e., outdoor activity should not be a new behavior. * Subjects must have used a sunscreen with SPF 50 or higher within the previous 9 months.

Exclusion criteria

* Subjects who have received or used an Investigational New Drug within the last 30 days. * Subjects who have been active participants in another clinical or subjective product performance study within the last 30 days. * Subjects who have a known allergy or sensitivity to sunscreen ingredients or test materials. * Subjects with respiratory allergies or asthma.

Design outcomes

Primary

MeasureTime frame
Feeling any discomfort after applying the product assessed by questionnaire15 minutes after each application

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026